Immunoassays have been used in recent years to detect the presence of infectious diseases. In order for the assay to be useful, it must detect a particular organism with a high degree of reliability. In most cases, this requires the isolation and reaction of antigens peculiar to the organism with corresponding antibodies, using an extraction procedure. For the test to be commerically successful, the extraction also needs to be relatively inexpensive, simple to use and rapid.
Examples of organisms which can be detected by immunoassay are: (1) Chlamydia trachomatis (herein C. trachomatis) which is one of two microbial species of the two microbial species of the genus Chlamydiaceae, order Chlamydiales. (2) Herpes simplex virus (HSV) which remains a serious problem. (3) Gonorrhea, which is a disease usually transmitted by sexual contact caused by a bacterium of the Neisseria genus, especially N. gonorrhea. (4) N. meningitidis and N. lactamica, which are also species of considerable medical and diagnostic interest.
In certain cases, it is necessary for reagents used in an extraction to be deposited in measured quantities and/or stored in an extraction container prior to its use resulting in more accurate and more rapid tests. An example of such an extraction container is more specifically discussed in U.S. Pat. No. 4,639,419 entitled "Immunological Color Change Test Involving Two Differently Colored Reagent Spots" issued on Jan. 27, 1987, disclosing a closed-ended tube where two reagents spots are placed into a well of the tube located in the closed end. Other patents disclosing deposits of reagents within an extraction device are U.S. Pat. Nos. 4,808,524 entitled "Test Kit and Method For The Determination of Streptococcus A Antigen" issued on Feb. 28, 1989, U.S. Pat. No. 4,673,639 entitled "Dry Form Micronitray Acid Streptococci Extraction-Agglutination Test" issued on Jun. 16, 1987 and U.S. Pat. No. 4,746,614 entitled "Extraction Device" issued on May 24, 1988.
However, standard extraction containers have not been adequate in keeping extraction reagents separated during the depositing and drying process or storage while allowing for adequate mixing upon reconstitution and for proper orientation of the container. As a result, extraction reagents have been allowed to interact before drying causing neutralization and inaccurate test results. Also, standard extraction containers have not aided the retention of dried extraction reagents within the closed end.
Such inadequacies in extraction containers have greatly reduced the accuracy of existing immunoassays employing the use of extraction containers. Furthermore, the extraction container is limited as to structural features that can be included, since the side walls adjacent the closed end need to be flexible enough to allow the container to be squeezed, to aid in dissolving the extraction reagent.
Therefore, prior to this invention, there has been a need for an extraction container which assists in more rapid and more accurate detection of antigens in an immunoassay through the use of effective depositing, drying and storage of extraction reagents in the extraction container.
An additional need has been to have predetermined measured quantities of reagents deposited, dried and stored in the extraction container in a manner producing in a more precise analytical determination.